Helius Announces FDA 510(k) Submission for PoNS Device Label Expansion in Stroke

Image for article Helius Announces FDA 510(k) Submission for PoNS Device Label Expansion in Stroke
News Source : Financial Post

News Summary

  • Helius Medical Technologies, Inc. (NASDAQ: HSDT) announced the filing of its U.S. Food and Drug Administration (FDA) 510(k) submission for the PoNS (Portable Neuromodulation Stimulator) device label expansion.
  • The submission was made with data generated in its Stroke Registrational Program (SRP) and was filed under its current FDA Breakthrough Device Designation.
  • PoNS efficacy and safety was clinically established from three clinical trials across 10 sites and 159 enrolled chronic stroke survivors with gait deficit due to stroke.
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